Anesthesia-Sparing System Targets Faster Ureteral Stone Treatment

Ureteral stone care is often delayed by operating room scheduling constraints and growing wait times, leaving a gap between diagnosis and treatment. With no fundamentally new therapeutic approach introduced in more than 30 years, the field has faced limited options for improving access and efficiency. A new system now offers a minimally invasive, anesthesia-sparing approach designed for use in outpatient and clinic settings.

Avvio Medical’s (San Francisco, CA, USA) Avvio System for Microbubble SonoLithotripsy was presented to urologists at the American Urological Association (AUA) 2026 Innovation Nexus on May 14, held alongside the AUA Annual Meeting from May 15–18 in Washington, DC. The presentation drew notable investor and strategic interest, with attendees viewing the technology as a timely response to a persistent challenge in ureteral stone care: delays between diagnosis and treatment caused by OR scheduling constraints and growing wait times. 

During the main meeting, Avvio hosted an invitation-only suite and held approximately 40 high-value meetings over three days with urologists, medtech strategics, venture capital and private equity firms, investment banks, and international stakeholders. Live demonstrations of a Limited Market Release prototype supported discussions on workflow, manufacturability, and adoption readiness.

The Avvio System is positioned as a first-line option for patients who cannot wait for an operating room slot. Using targeted microbubble-enabled acoustic cavitation to treat ureteral stones, the system is designed to shift stone care from the traditional operating room to hospital outpatient departments, ambulatory surgery centers, and outpatient clinic settings.

Regulatory progress includes Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The system remains investigational and is not cleared for commercial sale in the United States. 

A pivotal Enhanced Lithotripsy System (ELS) study is actively enrolling across sites in the United States. The company remains on track toward a data package it believes will support a favorable U.S. FDA market clearance discussion, and early results from the ongoing trial are encouraging. By avoiding routine general anesthesia and routine stent use, the system’s clinical profile is designed to expand treatment access for patients facing delays in the standard surgical pathway.

“AUA 2026 was a defining moment for Avvio Medical. Urologists immediately grasped what Microbubble SonoLithotripsy means for their patients: a way to act quickly, without waiting for an OR slot, without the burden of anesthesia and stents. The enthusiasm we heard across the meeting confirmed that we are not refining what already exists, we are building something the field has been waiting for,” said Paul Molloy, President and CEO of Avvio Medical.

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